Study of the Choroidal and Retinal Thickness in Relation to Axial Length.

Healthy Clinical Trial

— CHORAL  

Official title:

Study of the Choroidal and Retinal Thickness in Relation to Axial Length in Healthy Young Subjects With Swept-source Optical Coherence Tomography.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03377075
• Other study ID #: CHORAL-1249
• Status: Completed
• Start date: February 6, 2017
• Est. completion date: November 30, 2018

Study information

• Verified date: February 2019
• Source: Semmelweis University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The aim of the study is the non-invasive morphological evaluation of the choroid and the retina in relation to the length of the eyeball in healthy, young man and women.

Description:

The choroid is responsible for the oxygen supply of the outer retina, hence many diseases that affect the retina are originating from the choroid or at later stages influence the choroid as well. The functional efficiency of the choroid in a healthy subject is important. The thickness of the choroid is a marker for the extent of the vessels inside.

With optical coherence tomography (OCT) non-invasive and non-contact measurement of the choroidal and retinal thickness is possible. Swept-source OCT is one the latest developments of OCTs. Its increase wavelength allows deeper penetration than previous models and allows high resolution imaging.

OCTs are FDA approved machines, they are not considered experimental. The swept-source OCT machine (DRI OCT-1 Model Triton (plus), Topcon, Tokyo, Japan) used in the study is a CE marked commercially available medical device.

The goal of the study is to evaluate the choroidal and the retinal morphology in relation to the length of the eyeball (axial length - AL) in healthy, young adults.

There are several publications on this topic, most of them on asian populations.

In the study healthy, Caucasians in their twenties are recruited to minimize the aging effect on choroidal thickness.

Following informed consent, demographics are recorded, refraction is taken, axial length is measured with IOL Master 500 (Carl Zeiss AG, Germany) then OCT is performed.

Pupil dilation is not necessary. Images are stored digitally by abiding corresponding laws on personal data protection. Results are processed with statistical analysis.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 55
• Est. completion date: November 30, 2018
• Est. primary completion date: October 3, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 29 Years

Eligibility

Inclusion Criteria:

• 18 years of age or older, but less than 29 years of age

• Caucasian race

• Signed informed consent

Exclusion Criteria:

• Known epilepsy

• Inability to act

• Media opacity in the eye that would disturb imaging

Related Conditions & MeSH terms

• Healthy

Intervention

Device:
• AL measurement
IOL Master 500 (Carl Zeiss AG, Germany)
• OCT
Choroidal and retinal thickness measurement (DRI OCT-1 Model Triton (plus), Topcon, Tokyo, Japan)

Locations

Country	Name	City	State
Hungary	Semmelweis University, Department of Ophthalmology	Budapest

Sponsors (1)

Lead Sponsor	Collaborator
Semmelweis University

Country where clinical trial is conducted

Hungary, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Relation of choroidal thickness to axial length		Through study completion, 6 months
Primary	Relation of retinal thickness to axial length		Through study completion, 6 months
Secondary	Influence of age on results		Through study completion, 6 months
Secondary	Influence of gender on results		Through study completion, 6 months